February 28, 2009

Live Report from IMW - Day 2: Program Director, Anne Quinn Young

Day two of the XIIth IMW represented the transition day from a predominant focus on basic science and translational research to clinical data. The first clinical session of the day included representatives from 5 countries discussing recent and planned cooperative group Phase III clinical trials in each of their countries. Cooperative group trials are government organized and run, with industry funding and/or drug support provided in most cases. These trials tend to address questions that require data with long-term follow-up, such as: What is the optimal induction regimen prior to high-dose therapy and stem cell transplant? Is it better to combine three or four drugs upfront or sequence them? What is the value of a stem cell transplant in the age of novel therapies? What is the role of maintenance therapy? And so on.

Past cooperative group trials have addressed questions like the value of a second (consecutive) transplant; superiority of MP plus novel agents vs MP alone for newly diagnosed, transplant ineligible patients; optimal dosing of dexamethasone in combination with Revlimid (lenalidomide) for first-line therapy; and the role of Thalomid (thalidomide) as maintenance therapy.

What was striking about the planned trials from the various groups was their complementary nature. Many of the questions mentioned above have been addressed in countries such as France, Spain, Italy, the Netherlands, and the UK, where participation in clinical trials is often upwards of 50% of patients. With so many possible combinations and sequences, and so many critical late stage trials underway in the U.S. to address these questions, it is important for patients to participate in clinical trials. Otherwise, progress in the field will be slowed. To find a trial that is right for you or your loved one, call 866-603-MMCT (6628) or visit www.myelomatrials.org.

There were also many presentations of data related to novel investigational treatments in early stage (Phase I and II) clinical trials. Nine of these were from MMRC-supported trials! These new trials can be loosely broken into three groups: trials involving treatments that are already FDA-approved for other indications, eg, Zolinza (vorinostat) and Torisel (temsirolimus) and could be prescribed off-label for MM; investigational treatments (not FDA approved for any use) that represent second generation proteasome inhibitors such carfilzomib and NPI-0052 or pomalidomide, a new IMiD; and novel treatments that hit new targets such as perifosine or elotuzumab. But, with so many exciting new treatments, without increased clinical trial participation, we won’t know which are truly promising. Therefore, at any time in your disease – from first-line therapy to multiple relapses – it is critically important to consider a clinical trial.

Stay tuned for more clinical trials data in tomorrow’s report from IMW as well as new data from medical meetings in the spring including ASCO.